Careall Pain Relief Pm Tablet
FDA Label NDC 51824-108

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Pain Relief Pm (NDC 51824-108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain reliever

Nightime sleep aid

Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.  Quick Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take
• More than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.

Allergy Alert:Acetaminophen may cause sever skin reactions.  Symptoms may include: skin reddening, blisters, rash.  If a skin reaction occurs, stop use and seek medical help right away.

Do not use:

  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • if you have even had an allergic reaction to this product or any of its ingredients

    • Ask a doctor before use if you have

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

      • Ask a doctor or pharmacist before use if you are

      • taking the blood thinning drug warfarin
      • taking sedatives or tranquilizers

        • When using this product

        •drowsiness will occur

        •do not drive a motor vehicle or operate machinery

        •avoid alcoholic drinks

        Stop use and ask a doctor if

        •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

        •pain gets worse or last for more than 10 days.

        •fever gets worse or last for more than 3 days

        •redness or swelling are present

        •new symptoms occur.  These could be signs of a serious condition.

        If pregnant or breast-feeding, ask a health professional before use.

Directions

Do not use more than directed.  (see overdose warning)

Adults and children 12 years of age and older: Take 2 caplets at bedtime.  Do not take more than 2 caplets in 24 hours

Children under 12 years: do not use

Inactive Ingredients

colloidal silicon dioxide, copovidone, croscarmellose sodium, FD and C blue 1, hypromellose, lactose, magnesium, stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

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